Identification of Host Cell Proteins (HPCs) in Monoclonal Antibodies At Sub-ppm Levels Using the SYNAPT XS Mass Spectrometer

Application Note An Efficient LC/MS Workflow for Identification and Monitoring of Host Cell Proteins for Assisting Monoclonal Antibody Process Development Catalin E. Doneanu, Michael Daly, Ying Qing Yu Waters Corporation Abstract This application note introduced two analytical workflows for LC-MS…

IDENTIFICATION AND QUANTIFICATION OF HOST CELL PROTEIN IMPURITIES IN HIGH PURITY MONOCLONAL ANTIBODIES DOWN TO 1 PPM: AN INTER-LABORATORY STUDY Catalin Doneanu1, Scott J. Berger1, Malcolm Anderson2, Brad Williams3, Matt Lauber1, Asish Chakraborty1 and Weibin Chen1 1 Waters Corporation, Milford,…

[ APPLICATION NOTE ] A Comprehensive Approach for HCP Identification, Quantification, and Monitoring Based on a Single Dimension (1D) LC Separation Catalin Doneanu, 1 Sarah Lennon, 2 Malcolm Anderson, 2 Ian Reah, 3 Mal Ross, 3 Steven Anderson, 3 Ian…

Assay for Identification and Quantification of Host Cell Protein Impurities in High-Purity Monoclonal Antibodies Down to 1 ppm: An Inter-Laboratory Study Catalin E. Doneanu, Malcolm Anderson, Brad J. Williams, Matthew A. Lauber, Asish Chakraborty, and Weibin Chen Waters Corporation, Milford,…